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USP 797 INDEX

Preparations:

Are you prepared?

USP 797 Training

Solutions:

USP 797 Compliance
Solutions

On-Site USP 797
Gap Analysis Request

Sterile Preparations Documents:

USP 797 Pharmaceutical Compounding – Sterile Preparations

Update of USP 797 Document

JCAHO Timeline

USP 797 Compliance
Resources

Supplies & Equipment:

USP 797 Supplies & Equipment

MICRO-CLEAN'S
POSITION ON USP 797
Pharmaceutical Compounding
Sterile Preparations document:

Micro-Clean, Inc. wishes to stress the main reason for the USP 797 Pharmaceutical Compounding – Sterile Preparations document:

Improving Patient Safety

The USP document is designed to reduce or prevent harm to patients resulting from microbial contamination, bacterial endotoxins, and contamination of Pharmaceutical Compounded Sterile Preparations. It also covers gross ingredient percentages errors and the use of wrong components.

Contamination concerns are paramount as a vast majority of Compounding Sterile Preparations are aqueous injections. External contamination introduction through aqueous injections may have dire consequences to the patient, especially those under immuno-suppressed or immuno-compromised circumstances.

The USP797 describes the defined environmental controls process from material storage to aseptic manipulation of the Sterile Components. This process roughly mirrors the same strict environmental guidelines mandated to Pharmaceutical Manufacturers of Drugs produced under Aseptic Processing.

In the Manufacturing of Aseptic Drugs Process all components are maintained under defined and controlled environmental conditions until after they reach their final sealed packaging container to prevent the introduction of contaminants. This control of particulate and viable contaminants is accomplished through the use of HEPA filtration in cleanrooms as well as strict operating and personnel gowning procedures.

Pharmacy compounding takes these final sterile products and modifies them for the specified needs of a patient. The concern is preventing the introduction of contamination into the process.

The USP797 now requires defined and controlled environmental conditions for particulate and viable levels within the pharmacy anteroom, preparation and compounding areas as well as strict operating and personnel gowning procedures.

Micro-Clean has concerns with loopholes currently written into the USP 797 document:

1. The current version of USP797 allows barrier isolators to be located outside of controlled environments (not in HEPA filtered environments or cleanrooms). Isolators should be installed and used according to manufacturers' recommendations. This weakens the requirement for maintaining controlled environmental conditions of Aseptic Compounding Materials or Components. This lack of control permits an unknown amount of particulate and viable contamination to form or settle onto Compounding Materials or Components. The user must rely solely on their ability to wipe away contaminants prior to performing compounding operations. Our concern is this may jeopardize patient safety in favor of a “quick fix” alternative.
2. While barrier isolators are an emerging technology that allows for Pharmaceutical Compounding without direct contact with the compounding materials, caution should be exercised before selecting a barrier isolator over the time-tested HEPA filtered Laminar Flow Workbench.
   Items to consider are:
• The barrier isolator airflow patterns: A unidirectional flow isolator provides a HEPA filtered air sweeping action to prevent cross-contamination from previous compounding processes. These units have high air exchange rates to deliver and maintain ISO Class 5 air to critical surfaces.
• Some non-unidirectional airflow barrier isolators may slow down work processes due to their extended HEPA filtered air purge times (due to their low air exchange rates) to achieve ISO Class 5 conditions after opening access ports.
• Non-unidirectional airflow barrier isolators may increase the potential for cross-contamination when manipulating different drug products since they do not have a sweeping action.
• Barrier isolators may require extra operating procedures for its maintenance, monitoring and control.
• Barrier isolators may severely limit or restrict operator movement in compounding processes, take longer to purge out transfer stations, and require greater skill levels and dexterity when manipulating materials with front-access glove ports.

Only through proper and controlled environments can pharmacies compound a safe product that:

• Promotes and improves Patient Safety
• Maintains Industry Approval & Accreditation of Federal, State and Independent Governing Bodies
• Eliminates the potential of legal ramifications due to patient harm or injury

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